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GyrusAim LMS is a premier choice for life science companies, meeting the compliance standards of 21 CFR Part 11. This ensures that all training records adhere to FDA requirements for electronic signatures and documentation. GryusAim is a fully validated system to uphold data integrity and facilitate compliance with industry regulations.
With over 30 years of experience serving Life Sciences agencies, GyrusAim stands out as one of the premier learning management systems tailored for this sector. Here’s what sets us apart as the top choice for Life Sciences.
GyrusAim LMS adheres to the requirements of 21 CFR Part 11 with secure, audit-ready reporting, authentication protocols, and comprehensive audit trails that facilitate transparency and integrity of training documentation.
GyrusAim is a validated LMS, which is crucial for compliance with regulatory standards, as it provides assurance that the system can consistently produce accurate and reliable results.
Select the deployment option that aligns with your organization’s infrastructure and security requirements—whether cloud-hosted or self-hosted – ensuring adaptability while maintaining robust security and reliability.
Maintain detailed records of training completion, assessments, and certifications. These records serve as an audit trail, providing evidence of compliance during regulatory audits or inspections.
Centralize training materials and ensure that employees receive mandatory compliance training on topics such as safety protocols, regulations, and industry-specific standards.
Configure workflows specific to your compliance needs, including setting up automated reminders for training deadlines, approval processes for courses, and periodic assessments to ensure ongoing compliance and knowledge retention.
Track training that happens on the job so you can have a full picture of your employees training history.
GyrusAim LMS helps you to standardize training content delivery methods, ensuring consistency across the organization.
Streamline the orientation process for new employees and ensure consistent delivery of essential information.
Non-compliance with 21 CFR Part 11 regulations can lead to regulatory actions, fines, legal liabilities, and damage to the organization’s reputation, resulting in significant financial losses and operational disruptions.
The key features of GyrusAim for 21 CFR Part 11 compliance include electronic record keeping, electronic signatures, audit trails, data security measures, role-based access controls, and comprehensive reporting capabilities.
GyrusAim manages electronic records securely, allowing organizations to create, store, and manage them effectively. It also enables authorized users to sign electronic records digitally, ensuring compliance with 21 CFR Part 11 regulations while maintaining authenticity.
